Status:
WITHDRAWN
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Smallpox
Atopic Dermatitis
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatit...
Detailed Description
This is a randomized, double-blind, placebo-controlled study. subjects will be randomized to receive investigational vaccine or placebo at a ratio of 3.5:1, MVA3000 to placebo. All subjects will under...
Eligibility Criteria
Inclusion
- Adults at least 18 years old and who were born after 1971 with no previous history of smallpox vaccination
- Subjects must be in good general health Female subjects must not be pregnant or lactating and must agree to practice birth control during the course of the study
- Subjects must have a diagnosis of AD by an experienced clinician that includes a history of both major and minor diagnostic criteria
- At the time of screening, the subject must have "mild to moderate" AD.
Exclusion
- History or evidence of prior exposure to a vaccinia or MVA- containing product
- known or suspected history of immunodeficiency other than AD
- Known or suspected impairment of major organ function
- Known history or diagnosis of cardiac disease or cerebrovascular disease
- presence of acute, chronic, or active exfoliative skin conditions other than AD, open wounds, or burns.
- Dementia or history of seizures
- Known allergies to MVA or any known components of the vaccine
- transfusion of blood, organ transplantation, or treatment with any blood product
- morbid obesity, or a BMI less than or equal to 18.5
- history of or current drug or alcohol abuse (except nicotine) within the past 6 months or any history of IV drug use
- history of major psychiatric illness except major depression not requiring medical therapy.
- subjects who have participated in another investigational drug or vaccine trial within 30 days of study day 0
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00389103
Start Date
October 1 2006
End Date
January 1 2007
Last Update
January 22 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
3
DermResearch, Inc.
Austin, Texas, United States, 78759